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Nevin Manimala Statistics

Is sacral neuromodulation effective and safe in pregnancy? A systematic review

Neurourol Urodyn. 2023 Jun 8. doi: 10.1002/nau.25224. Online ahead of print.

ABSTRACT

OBJECTIVE: We systematically assessed all available evidence on the efficacy and safety of sacral neuromodulation (SNM) in pregnancy.

METHODS: On September 2022, a thorough search was done on Ovid, PubMed, Scopus, ProQuest, Web of Science, and The Cochrane Library. We chose studies that included pregnant women who had SNM previously. Two authors independently evaluated the quality of the study using a standardized tool of JBI. Studies were given a risk of bias rating of low, moderate, or high. Given the descriptive nature of this study, we utilized descriptive statistics to report demographic and clinical features. For continuous variables, we used mean and standard deviation, and for dichotomous data, we used frequencies and percentages.

RESULTS: Out of 991 abstracts screened, only 14 studies met our inclusion criteria and were included in the review. Overall, the quality of the evidence available from the literature is low based on the design of the included studies. Fifty-eight women, including 72 pregnancies, had SNM. The indication of SNM implantation was filling phase disorders in 18 cases (30.5%), voiding dysfunction in 35 women (59.3%), IC/BPS in two cases (3.5%), and fecal incontinence. In 38 pregnancies (58.5%), the SNM status was ON during pregnancy. Forty-nine cases delivered a full-term baby (75.4%), 12 cases had pre-term labor (18.5%), two miscarriages, and two postterm pregnancies happened. The most complications in patients with devices were urinary tract infection in 15 women (23.8%), urinary retention in six patients (9.5%), and pyelonephritis in two cases (3.2%). The findings revealed that when the device was deactivated, 11 cases out of the 23 patients (47.8%) had full-term pregnancies, while in ON status, 35 out of the 38 pregnant women (92.1%) had full-term pregnancies. Nine preterm labors in OFF (39.1%), and two in ON status (5.3%) were recorded. The results revealed that this difference was statistically significant (p = 0.002), and those who turned SNM of them off had more preterm labor. Although the studies reported all neonates had a healthy status, two children had chronic motor tic problems and a pilonidal sinus in a case with an active SNM in pregnancy. However, there was no association between the SNM status and pregnancy or neonatal complications (p = 0.057).

CONCLUSION: SNM activation in pregnancy seems safe and effective. The choice of whether to activate or deactivate SNM should be made on an individual basis given the current SNM evidence.

PMID:37288591 | DOI:10.1002/nau.25224

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Textbook outcomes in liver surgery for gallbladder cancer patients treated with curative-intent resection: a multicenter observational study

Int J Surg. 2023 Jun 6. doi: 10.1097/JS9.0000000000000510. Online ahead of print.

ABSTRACT

BACKGROUND: Cholecystectomy, hepatectomy, and lymphadenectomy are recommended as the curative treatment for resectable gallbladder cancer (GBC). Textbook outcomes in liver surgery (TOLS) is a novel composite measure that has been defined by expert consensus to represent the optimal postoperative course after hepatectomy. This study aimed to determine the incidence of TOLS and the independent predictors associated with TOLS after curative-intent resection in GBC patients.

METHODS: All consecutive GBC patients who underwent curative-intent resection between 2014 and 2020 were enrolled from a multicenter database from 11 hospitals as the training and the internal testing cohorts, and Southwest Hospital as the external testing cohort. TOLS was defined as no intraoperative grade greater than or equal to 2 incidents, no grade B/C postoperative bile leaks, no postoperative grade B/C liver failure, no 90-day postoperative major morbidity, no 90-day readmission, no 90-day mortality after hospital discharge, and R0 resection. Independent predictors of TOLS were identified using logistic regression and were used to construct the nomogram. The predictive performance was assessed using the area under the curve and calibration curves.

RESULTS: TOLS was achieved in 168 patients (54.4%) and 74 patients (57.8%) from the training and internal testing cohorts, and the external testing cohort, respectively. On multivariate analyses, age less than or equal to 70 years, absence of preoperative jaundice (total bilirubin≤3 mg/dl), T1 stage, N0 stage, wedge hepatectomy, and no neoadjuvant therapy were independently associated with TOLS. The nomogram that incorporated these predictors demonstrated excellent calibration and good performance in both the training and external testing cohorts (area under the curve: 0.741 and 0.726).

CONCLUSIONS: TOLS was only achieved in approximately half of GBC patients treated with curative-intent resection, and the constructed nomogram predicted TOLS accurately.

PMID:37288584 | DOI:10.1097/JS9.0000000000000510

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What is the best score for predicting difficult laparoscopic cholecystectomy? A diagnostic trial study

Int J Surg. 2023 Jun 6. doi: 10.1097/JS9.0000000000000354. Online ahead of print.

ABSTRACT

BACKGROUND: Multiple scores have been created in order to predict difficult cholecystectomy, nonetheless there is not a consensuated standard on which to use. The importance of a predictive score to be able to establish a difficult cholecystectomy would be a relevant instrument in order to better inform the patient, properly call for help when needed, choose the correct staff, and schedule and plan the surgical procedure accordingly.

METHODS: A diagnostic trial study was performed. All different predictive scores for difficult cholecystectomy were calculated for each patient. The correlation between the preoperative score and cholecystectomies considered as “difficult” were measured estimating the preoperative score’s predictive value using a ROC curve in order to predict findings for difficult cholecystectomy.

RESULTS: A total of 635 patients between 2014-2021 were selected. Selected patients had a mean age of 55.0 (IQR: 28.00) and were mostly female (64.25%). Surgical outcomes of patients with difficult cholecystectomy had statistically significant higher rates of subtotal cholecystectomies, drain usage, complications and reinterventions, prolonged surgical times, and longer hospital stay. When analyzing the predictive value on each of the different scores applied, score 4 had the highest performance for predicting difficult cholecystectomy with an AUC=0.783 (CI 95% 0.745-0.822).

CONCLUSIONS: Difficult cholecystectomies are associated with worse surgical outcomes. The standardization and use of predictive scores for difficult cholecystectomy must be implemented in order to improve surgical outcomes as a result of more meticulous planning when scheduling the procedure.

PMID:37288543 | DOI:10.1097/JS9.0000000000000354

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Utilization of PAX1 methylation test for cervical cancer screening of non-HPV16/18 high-risk HPV infection in women

Future Oncol. 2023 Jun 8. doi: 10.2217/fon-2023-0226. Online ahead of print.

ABSTRACT

Aim: To evaluate the clinical performance of PAX1 methylation (PAX1m) and cytology for patients with non-HPV16/18 high-risk HPV (hrHPV) infection. Methods: Cervical exfoliated cells from 387 outpatients with non-HPV16/18 hrHPV – positive were collected for cytology and PAX1m assays. Results: The PAX1m level increased with the severity of cytology and histopathology. For cervical intraepithelial neoplasia (CIN)CIN2+/CIN3+, the areas under the curve were both 0.87. The specificity and positive predictive value (PPV) of PAX1m were greater than abnormal cytology (CIN2+ specificity: 75.5 vs 24.8%; PPV: 38.8 vs 18.7%; CIN3+ specificity: 69.3 vs 22.7%; PPV: 14.0 vs 6.7%). Conclusion: PAX1m increased specificity and PPV for CIN2+/CIN3+ compared with cytology for women with non-HPV16/18 hrHPV (+).

PMID:37288536 | DOI:10.2217/fon-2023-0226

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Trajectories of Functional Decline in Older Adults: A Latent Class Growth Curve Analysis

West J Nurs Res. 2023 Jun 8:1939459231180365. doi: 10.1177/01939459231180365. Online ahead of print.

ABSTRACT

There have been few studies examining trajectories of functional decline among older adults in the United States using large representative databases. The purpose of this study was to describe the mean trajectory of functional decline for a representative sample of US older adults, to determine the optimal number of latent classes within that sample, and to identify key differences between the classes on select variables. Through the use of link functions, non-linear trajectories can be modeled. Three classes were identified and were named Rapid Decline, Late Decline, and High Baseline. The Late Decline Group was the most numerous and was characterized by low initial functional disability with a steep rise starting around age 85. The Rapid Decline Group also had low initial functional disability, but decline started around age 80. The High Baseline Group had high initial functional disability and less steep trajectory. Age and comorbidity were the most influential factors in functional decline. Race was statistically significant but the difference disappeared when controlling for other covariates. Sex did not significantly influence the trajectory. There were significant differences among the classes for mortality during study, initial age, initial functional status, and for several specific comorbidities: arthritis, diabetes, lung disease, and stroke.

PMID:37288523 | DOI:10.1177/01939459231180365

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Minimal clinically important difference of the Michigan Hand Outcomes Questionnaire score and the pain visual analogue scale in conservative treatment of trigger finger

J Hand Surg Eur Vol. 2023 Jun 8:17531934231176663. doi: 10.1177/17531934231176663. Online ahead of print.

ABSTRACT

We investigated the minimal clinically important difference (MCID) of the Michigan Hand Outcomes Questionnaire (MHQ) and the pain visual analogue scale (VAS-pain) after conservative treatment of trigger finger. This secondary analysis of a randomized controlled trial compared pain reduction, symptoms and functional improvement at 12 weeks. Patients included were at least 18 years old and able to complete MHQ and VAS-pain at enrolment and 12 weeks after treatment. The MCIDs of MHQ and VAS-pain were evaluated using a distribution-based, anchor-based and receiver operating characteristic (ROC) curve-based approach. Of the 117 patients, the MCIDs of MHQ and VAS-pain using a distribution-based approach were 5.3 and 0.6, respectively; applying ROC method were 23.5 and 2.5, respectively; and using anchor questions were 15 and 2, respectively. These MCID values by anchor-based method with a minimal difference of 15 for MHQ and 2 for VAS-pain are recommended as primary evidence to determine clinically significant improvement after conservative treatment of trigger finger.Level of evidence: I.

PMID:37288517 | DOI:10.1177/17531934231176663

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“A morning cortisol is the most effective clinical predictor of short synacthen test outcome”: A tertiary care centre experience

Clin Endocrinol (Oxf). 2023 Jun 8. doi: 10.1111/cen.14934. Online ahead of print.

ABSTRACT

OBJECTIVE: Increasing referrals to Endocrinology with nonspecific symptoms of suspected adrenal insufficiency (AI) has increased use of the short-synacthen test (SST). Prevailing resource and safety concerns emphasise importance of patient selection criterion to optimise SST use. This study aimed to (1) document the adverse event profile of the SST (2) identify any pretest predictors of SST outcome.

DESIGN, PATIENTS AND MEASUREMENTS: Retrospective data analysis of all patients referred for SST in Oxford from 2017 to 2021. Pretest clinical variables (age, sex, BMI, blood pressure and electrolytes), symptoms (fatigue, dizziness, weight loss) and pretest morning cortisol were included in the statistical model with the aim of identifying any variables that could predict SST outcome in Group 1 primary AI, Group 2 central AI and Group 3 glucocorticoid induced AI. Symptoms and signs during and post SST were also noted with the aim of describing adverse effects to synacthen across a large cohort.

RESULTS: A total 1480 SSTs (Males:38%, age 52 [39-66] years) were performed: 505 (34.1%) in Group 1, 838 (57%) in Group 2, and 137 (9.3%) in Group 3. Adverse-effects were recorded in 1.8% of tests, including one episode of anaphylaxis. Pretest morning-cortisol was the only predictor for an “SST pass” (whole cohort: B = 0.015, p < 0.001, Group 1: B = 0.018, p < .001; Group 2: B = 0.010, p < 0.012; Group 3: B = 0.018, p = <.001). A threshold of ≥343 nmol/l (receiver-operating characteristic [ROC] area under the curve [AUC] = 0.725, 95% confidence interval [CI] 0.675-0.775, p < 0.001) for the whole cohort, ≥300 nmol/L (ROC AUC = 0.763, 95% CI 0.675 to 0.850, p < 0.001) for Group 1, ≥340 nmol/L (ROC AUC = 0.688, 95% CI 0.615 to 0.761, p < 0.001) for Group2, and ≥376 nmol/L [baseline cortisol] (ROC AUC = 0.783, 95% CI 0.708 to 0.859, p < 0.001) for Group 3, predicted an ‘SST pass’ with 100% specificity.

CONCLUSIONS: Adverse effects to synacthen are rare. Pretest morning cortisol is a reliable predictor for SST outcome and is a helpful tool to rationalise use of the SST. Predictive morning-cortisol thresholds vary according to the aetiology of AI.

PMID:37288515 | DOI:10.1111/cen.14934

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Traffic-Calming Measures and Road Traffic Collisions and Injuries: a Spatiotemporal Analysis

Am J Epidemiol. 2023 Jun 7:kwad136. doi: 10.1093/aje/kwad136. Online ahead of print.

ABSTRACT

Traffic-calming measures (TCMs) are physical modifications to the road network aimed at making the roads safer. Although studies have reported reductions in road crashes and injuries tied to the presence of TCMs, they have been criticized for their pre-post designs. This study aims to complement our knowledge of TCMs effectiveness by assessing their impact using a longitudinal design. The implementation of eight TCMs, including curb extensions and speed humps, was evaluated at the intersections and census tract levels in Montreal, Canada from 2012 to 2019. The primary outcome was fatal or serious collisions among all road users. Inference was performed using a Bayesian implementation of Conditional Poisson regression in which random effects were used to account for the spatiotemporal variation in collisions. TCMs were generally implemented on local roads, although most collisions occurred on arterial roads. Overall, there was weak evidence that TCMs were associated with study outcomes. However, subgroup analyses of intersections on local roads suggested a reduction in collision rates due to TCMs (median IRR: 0.31; 95% Credible Interval: 0.12 – 0.86). To improve road safety, effective counterparts of TCMs on arterial roads must be identified and implemented.

PMID:37288501 | DOI:10.1093/aje/kwad136

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Comparison of radiography and CT for the evaluation of third carpal bone slab fractures in Thoroughbred racehorses

Vet Radiol Ultrasound. 2023 Jun 8. doi: 10.1111/vru.13255. Online ahead of print.

ABSTRACT

Slab fractures of the third carpal bone (C3) are a common cause of lameness in Thoroughbred racehorses. Information on fracture morphology is commonly obtained from radiographs or CT. This retrospective, methods comparison aimed to explore the agreement between radiography and CT for imaging C3 slab fractures and discuss the contribution of the latter to clinical case management. Thoroughbred racehorses with a slab or incomplete slab fracture of C3 identified on radiographs that subsequently underwent CT examination were included. Fracture characteristics (location, plane, classification, displacement, comminution) and fracture length as a percentage of the proximodistal length of the bone, termed the proximodistal fracture percentage (PFP) were recorded independently from both modalities and then compared. Across all fractures (n = 82) radiographs and CT showed slight agreement on the presence of comminution (Cohen’s Kappa (κ) 0.108, P 0.031) and moderate agreement on fracture displacement (K 0.683, P < 0.001). Computed tomography identified comminution in 49 (59.8%) and displacement in nine (11.0%) fractures that were not detected by radiographs. Half of the fractures were only seen on flexed dorsoproximal-dorsodistal oblique (DPr-DDiO) radiographs and therefore were of unknown length without additional CT imaging. Incomplete fractures that could be measured on radiographs (n = 12) had a median (IQR) PFP of 40% (30%-52%) on radiographs and 53% (38%-59%) on CT, a statistically significant difference (P = 0.026). Radiography and CT showed the poorest agreement when determining the presence of comminution. Additionally, radiography often underestimated the incidence of displacement, and fracture length, and resulted in more fractures being classified as incomplete when compared to CT.

PMID:37288478 | DOI:10.1111/vru.13255

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Overview of glottic laryngeal cancer treatment recommendation changes in the NCCN guidelines from 2011 to 2022

Cancer Rep (Hoboken). 2023 Jun 7:e1837. doi: 10.1002/cnr2.1837. Online ahead of print.

ABSTRACT

BACKGROUND: The treatment of glottic cancer remains challenging, especially with regard to morbidity reduction and larynx preservation rates. The National Comprehensive Cancer Network (NCCN) has published guidelines to aid decision-making about this treatment according to the tumor site, clinical stage, and patient medical status.

AIM: The present review was conducted to identify changes in the NCCN guidelines for glottic cancer treatment made between 2011 and 2022 and to describe the published evidence concerning glottic cancer treatment and oncological outcomes in the same time period.

METHODS AND RESULTS: Clinical practice guidelines for head and neck cancer published from 2011 up to 2022 were obtained from the NCCN website (www.NCCN.org). Data on glottic cancer treatment recommendations were extracted, and descriptive analysis was performed. In addition, a review of literature registered in the PubMed database was performed to obtain data on glottic cancer management protocols and treatment outcomes from randomized controlled trials, systematic reviews, and meta-analyses published from 2011 to 2022. In total, 24 NCCN guidelines and updates and 68 relevant studies included in the PubMed database were identified. The main guideline changes made pertained to surgical and systemic therapies, the consideration of adverse features, and new options for the treatment of metastatic disease at initial presentation. Early-stage glottic cancer received the most research attention, with transoral endoscopic laser surgery and radiotherapy assessed and compared as the main treatment modalities. Reported associations between treatment types and survival rates for this stage of glottic cancer appear to be similar, but functional outcomes can be highly compromised.

CONCLUSION: NCCN panel members provide updated recommendations based on currently accepted treatment approaches for glottic cancer, constantly reviewing new surgical and non-surgical techniques. The guidelines support decision-making about glottic cancer treatment that should be individualized and prioritize patients’ quality of life, functionality, and preferences.

PMID:37288471 | DOI:10.1002/cnr2.1837